A Pilot Study of Sequential ONCOS-102, an Engineered Oncolytic Adenovirus Expressing GMCSF, and Pembrolizumab in Patients With Advanced or Unresectable Melanoma Progressing After Programmed Cell Death Protein 1 (PD1) Blockade
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ClinicalTrials.gov Identifier: NCT03003676 |
Recruitment Status :
Active, not recruiting
First Posted : December 28, 2016
Last Update Posted : October 8, 2020
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Tracking Information | |||
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First Submitted Date ICMJE | December 19, 2016 | ||
First Posted Date ICMJE | December 28, 2016 | ||
Last Update Posted Date | October 8, 2020 | ||
Study Start Date ICMJE | December 2016 | ||
Actual Primary Completion Date | July 2020 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Incidence of treatment-emergent adverse events including treatment-emergent serious adverse events assessed by CTCAE. [ Time Frame: 6 months ] | ||
Original Primary Outcome Measures ICMJE |
Safety of sequential treatment with ONCOS-102 followed by pembrolizumab by assessment of laboratory parameters (routine haematology and biochemistry), vital signs and recording of adverse events. [ Time Frame: 6 months ] | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||
Descriptive Information | |||
Brief Title ICMJE | A Pilot Study of Sequential ONCOS-102, an Engineered Oncolytic Adenovirus Expressing GMCSF, and Pembrolizumab in Patients With Advanced or Unresectable Melanoma Progressing After Programmed Cell Death Protein 1 (PD1) Blockade | ||
Official Title ICMJE | A Pilot Study of Sequential ONCOS-102, an Engineered Oncolytic Adenovirus Expressing GMCSF, and Pembrolizumab in Patients With Advanced or Unresectable Melanoma Progressing After PD1 Blockade | ||
Brief Summary | This is a multi center, phase I pilot study of sequential ONCOS-102 and pembrolizumab in patients with advanced or unresectable melanoma progressing after PD1 blockade. The primary objective of the study is to determine the safety of sequential treatment with ONCOS-102 followed by pembrolizumab. The protocol aims to enroll patients into two cohorts: Part I: up to 12 patients will receive sequential treatment with ONCOS-102 followed by pembrolizumab. Part II: up to 12 patients will receive an initial treatment phase with ONCOS-102 followed by a treatment phase with ONCOS-102 in combination with pembrolizumab. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 1 | ||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Advanced or Unresectable Melanoma Progressing After PD1 Blockade | ||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Experimental: ONCOS-102+cyclophosphamide+pembrolizumab
Part I: Patients will receive 3 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, and 8) at 3x10^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. They will then receive pembrolizumab i.v., 2mg/kg or 200mg flat dose, on day 22 (Week 3) and every 3 weeks thereafter until the end of treatment visit on day 169 (Week 24). Part II: Patients will receive 4 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, 8 and 15) at 3x10^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. ONCOS-102 will be given in combination with Pembrolizumab starting on Day 22/Week 3 and every three weeks thereafter until Day 169/Week 24 or until unacceptable toxicity or clinically relevant disease progression, whichever occurs first. Pembrolizumab will be given according to institutional practice (2mg/kg or 200mg flat dose). Interventions:
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Publications * | Kuryk L, Møller AW, Jaderberg M. Combination of immunogenic oncolytic adenovirus ONCOS-102 with anti-PD-1 pembrolizumab exhibits synergistic antitumor effect in humanized A2058 melanoma huNOG mouse model. Oncoimmunology. 2018 Oct 29;8(2):e1532763. doi: 10.1080/2162402X.2018.1532763. eCollection 2019. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Active, not recruiting | ||
Actual Enrollment ICMJE |
21 | ||
Original Estimated Enrollment ICMJE |
12 | ||
Study Completion Date ICMJE | Not Provided | ||
Actual Primary Completion Date | July 2020 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Norway, United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT03003676 | ||
Other Study ID Numbers ICMJE | ONCOS C824 | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Targovax ASA ( Targovax Oy ) | ||
Study Sponsor ICMJE | Targovax Oy | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Targovax ASA | ||
Verification Date | October 2020 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |